Califf: I’ll never lower FDA’s approval standards

2:20 p.m., Nov. 17: This story was updated

WASHINGTON — Dr. Robert Califf, President Barack Obama’s nominee to lead the Food and Drug Administration, defended his acceptance of drug industry funding Tuesday and promised never to lower the agency’s safety standards.

But those promises weren’t good enough for Senator Bernie Sanders of Vermont, the Democratic presidential candidate, who told Califf he wouldn’t support him because the nation needs an “aggressive” FDA commissioner and “I’m not hearing that.”

In testimony at his Senate confirmation hearing, Califf, who came to FDA earlier this year after a long career at Duke University, where he helped found the university’s clinical research center, acknowledged that pharmaceutical companies funded many studies he oversaw. But he insisted that none of them were allowed to alter or hide the results.

Democratic Senator Elizabeth Warren of Massachusetts, however, insisted she get to read the fine print on his Duke contracts before deciding whether to support him.

Under Warren’s sharp questioning, Califf promised to strike the right balance between approving new drugs quickly and making sure they’re safe.

“I think if you look at my record, I’ve never been a proponent of lowering standards. If anything, I’ve argued for raising them,” he told Warren. “That doesn’t mean we couldn’t be quicker in some cases.”

But Sanders — who had previously announced he wouldn’t support Califf — grilled the potential FDA commissioner in an unsuccessful attempt to get him to support reimportation of cheaper prescription drugs from other countries and allowing Medicare to negotiate lower drug prices, two key proposals in Sanders’ plan to rein in drug costs.

“We all want great medicines to come onto the market, and I respect the work you have done. But at the end of the day, people are dying … because we have been extraordinarily weak in taking on the pharmaceutical industry,” Sanders told Califf. “I believe we need a commissioner who is going to stand up to the pharmaceutical industry, so I have to say to you with regret you are not that person.”

Most of the questions Califf received from Republicans and Democrats on the committee were polite and restrained, and he’s still expected to win confirmation. Califf told STAT he was “very pleased” with the hearing.

But his past financial support from the pharmaceutical industry quickly became the running theme of the questions from Democratic senators.

In response to questions from Warren and Senator Patty Murray of Washington, the ranking Democrat on the Health, Education, Labor and Pensions Committee, Califf said he had taken all proper precautions to ensure the Duke research was not biased. He also said he rejected many potential drug industry collaborations because the companies would not go along with his requirements.

“The design of the trial is something that is done jointly and very publicly,” Califf said, “so it actually involved industry, academia — and now patients — and the FDA. It’s a very public process.”

He added that in “70 percent of the studies I wanted to do, we could not do” because the companies wouldn’t go along with his conditions, including granting access to the databases that contain all of the research generated during clinical trials.

Pressed by Warren as to how much influence the drug industry had on the Duke trials, Califf declared that “industry has a right to make suggestions, but no right to censor or make changes unless the authors agree.”

Warren did not appear to be impressed. She said she had recently ordered copies of all the details on all the research contracts between Duke and the industry, under Califf’s leadership, and would not vote on the confirmation until she had reviewed them.

Senator Lamar Alexander of Tennessee, the Republican who chairs the committee, said Califf had been through an exhaustive vetting process to make sure he had no conflicts of interest.

“My staff tells me they haven’t found anything that would call into doubt your ability to lead the FDA fairly and impartially,” he said.

Alexander also noted that the Office of Government Ethics has coached Califf on when he will need to recuse himself from regulatory decisions.

And Alexander declared that the FDA doesn’t have to be a barrier to industry — echoing a comment Califf made during a 2014 presentation, now getting widespread attention among his critics, in which he said government regulation can be a “barrier” to innovation.

Califf also responded to questions from Republican Johnny Isakson of Georgia about why the FDA weighs in on so many subjects through guidance letters, which don’t have to go through a cost-benefit analysis or a comment period, rather than regulations. He said there are times when the agency needs the full force of regulations, but that the guidance letters still have a value because “everyone wants to know what the FDA is thinking.”

Senators have until Nov. 25 to send Califf any follow-up questions.